A Study of Topical BX005-A in Subjects With Moderate to Severe Atopic Dermatitis

NCT ID: NCT05240300

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-06-30

Brief Summary

The purpose of study BMX-05-001 is to evaluate the safety, tolerability, efficacy, and pharmacodynamics of BX005-A compared to vehicle administered topically in adult subjects with moderate to severe atopic dermatitis (AD).

Detailed Description

BMX-05-001 is a double-blind (Sponsor open), randomized, vehicle-controlled, first-in-human, Phase 1b/2a study to evaluate the safety, tolerability, efficacy, and pharmacodynamics of BX005-A compared to vehicle administered topically twice daily for 8 weeks to lesional areas in adult subjects with moderate to severe atopic dermatitis (AD).

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BX005-A

twice daily topical application x 8 weeks

Group Type: EXPERIMENTAL

BX005-A

Intervention Type: BIOLOGICAL

phage gel

Vehicle

twice daily topical application x 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

vehicle gel

Interventions

BX005-A

phage gel

Intervention Type: BIOLOGICAL

Placebo

vehicle gel

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or female ≥ 18 years old

2. Confirmed clinical diagnosis of active AD with at least a 6-month history and clinically stable AD for ≥ 1 month

3. Clinical diagnosis of moderate or severe AD with a vIGA-AD score of ≥ 3 and a lesion vIGA-AD score ≥ 3 in the target AD skin lesion

4. BSA with AD of 2%-30%, excluding scalp

5. Colonized with S. aureus in at least one AD skin lesion

6. Female subjects of non-childbearing potential must meet at least 1 of the following: postmenopausal status; documented hysterectomy and/or bilateral oophorectomy; or medically confirmed ovarian failure. All other female subjects (including those who have undergone tubal ligation) are of childbearing potential.

7. Female subjects of childbearing potential who have a negative urine pregnancy test

8. Effective contraceptive method for female subjects of childbearing potential and for male subjects

9. Able to understand study procedures and attend all study visits

10. Willing to refrain from use of all other systemic or topical agents for the treatment of AD or the prevention of complications of AD (e.g., secondary infection)

Exclusion Criteria

1. Active skin infection and/or systemic infection requiring systemic or topical antimicrobial agents and/or a skin drainage procedure, or a history of recurrent bacterial skin infections

2. Other concurrent skin diseases which could interfere with the diagnosis and/or management of AD (e.g., psoriasis, contact dermatitis), or presence of open, chronic non-healing wounds in their treatable AD lesions

3. Known hypersensitivity to study drug, its excipients, simethicone, and/or any emollient to be used in study

4. Planned treatment with a prohibited medication during study, or received a prohibited medication within time frame noted below, prior to first dose of study drug:

Must be discontinued at least 28 Days prior to Day 1:

• Systemic corticosteroids
• Systemic JAK inhibitors and immunosuppressive agents
• Nonbiologic investigational agent or device
• Total body phototherapy

Must be discontinued at least 14 Days prior to Day 1:

• Systemic antimicrobials
• Probiotics and prebiotics
• Prescription skin barrier repair products

Must be discontinued at least 7 Days prior to Day 1:

• Topical therapies for AD
• Topical antimicrobials and antiseptic cleansers
• Use of antibacterial soaps or topical sodium hypochlorite-based products
• Current emollient use (need to convert to study emollient 7 days prior to Day 1)

5. Currently being treated with biologic agents; exception: may be enrolled if dupilumab was discontinued at least 12 weeks prior to Day 1, or if other biologics were discontinued at least 5 half-lives prior to Day 1.

6. Female subjects who are pregnant, breastfeeding, or planning a pregnancy, or are of childbearing potential and not using an effective and allowed form of contraception.

7. Enrolled in another investigational study 30 days prior to Screening or 90 days prior to Screening if investigational agent was a phage product.

8. Other medical and/or psychiatric conditions which makes the subject inappropriate for study participation, increases likelihood that the subject will not be able to comply with study therapy or procedures and/or which places the subject at undue risk

9. Active abuse of alcohol and/or illicit drugs or a history of such abuse that would make it difficult for the subject to comply with study and/or place subject at undue risk

10. Known infection with human immunodeficiency virus (HIV) or other immunodeficiency disorder.

11. Current or prior history of a malignant neoplasm other than previously treated non-melanoma skin cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruho Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

BiomX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urania Rappo, MD

Role: STUDY_DIRECTOR

BiomX, Inc.

Other Identifiers

BMX-05-001

Identifier Type: -

Identifier Source: org_study_id